NCT03445897

Brief Summary

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 21, 2018

Last Update Submit

February 23, 2018

Conditions

Leishmaniasis, Cutaneous

Outcome Measures

Primary Outcomes (1)

  • Lesion size

    area of lesion

    6 months post therapy

Secondary Outcomes (2)

  • adverse effects at site

    days 1, 3, 5 of therapy

  • systemic adverse effects

    days 1 to 28 of therapy

Study Arms (1)

Intervention

EXPERIMENTAL

miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Drug: miltefosine plus intralesional pentamidine

Interventions

miltefosine plus intralesional pentamidineDRUG

miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • one ulcerative lesion ≤ 900 mm2 in total area,
  • ≥ 12 years,
  • parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
  • no antileishmanial therapy in the last 3 months,
  • no mucosal lesions,
  • no history of significant concomitant diseases including immunosuppression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosine

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 26, 2018

Study Start

January 31, 2016

Primary Completion

January 31, 2018

Study Completion

February 21, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02